Facilitating Medical Innovation and Technology: The Role of FDA

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In attempting to arrive at the truth, I have
applied everywhere for information, but in
scarcely an instance have I been able to
obtain hospital records fit for any purposes
of comparison. If they could be obtained, they
would show howmoney was being spent, what amount
of good was really being done with it.. and
these improved statistics would tell us more of
the relative value of particular operations and
modes of treatment .. and the truth thus
ascertained would enable us to save life and
suffering, and to improve the treatment and
management of the sick Florence
Nightingale Notes on hospitals (1859, revised
1863)
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Update on CDRH Informatics/UDI Work

• Terrie Reed
• Senior Policy Analyst
• FDA Center for Devices and Radiological Health
• 3/12/10

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How do you define Health Informatics?

• Methods used to optimize the acquisition,
  storage, retrieval, and analysis of health
  information. Tools include not only computers but
  also clinical guidelines, formal medical
  terminologies, and information and communication
  systems.

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How do you define Health Informatics?

• For CDRH
• Standard Vocabularies
• Standard Methods of Data Exchange
• Alignment of Database Information
• GOAL of Health Informatics
• Facilitate sharing of data across TPLC and with
  other Stakeholders

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CDRH Informatics Work

• Examples of Standard Vocabularies
• Event Problem Codes Fully Live 4/2/2010
• Evaluation Codes Under Development
• Global Medical Device Nomenclature (GMDN)
• Product Dictionary Unique Device Identifier
  (UDI)

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CDRH Informatics Work (contd)

• Examples of Standard Methods of Data Exchange
• Health Level Seven (HL7)
• Regulated Product Submission (RPS) STED
• Individual Case Safety Report (ICSR) - eMDR
• Structure Product Labeling (SPL) Product
  Information Content of the Label
• Examples of Aligning Databases
• Product Codes gtUDI

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The Need for UDI

• US Has No Good System To Track Medical Implants
• AP Enterprise United States Has No Reliable
  System To Track
• Defective Medical Implants
• (AP) New York October 5, 2009. Three years ago,
  the maker of a surgical clip called the Hem-o-lok
  issued an urgent recall notice warning doctors to
  stop using the fasteners on living kidney donors.
  It said the clips could dislodge. in their
  bodies, with "serious, even life-threatening
  consequences. Not everyone got the message. Last
  October, a surgeon in Brooklyn used one of the
  clips to tie off Michael King's renal artery when
  he donated a kidney to his ailing wife. Twelve
  hours later, the clip popped off. King bled to
  death internally in the hospital as his wife lay
  helplessly nearby. He was 29.
• http//www.cbsnews.com/stories/2009/10/05/ap/healt
  h/main5364655.shtml

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Device Information Lifecycle
Rentals
GPOs
Clinical Substitution
Manufacturer
Sold
Distributor
Device X Lot Y Exp Date Z
Physicianpreference
Hospital
Reuse
Direct
Recall
Reorder
Off-master purchase
Clinical Use
Unit
Sales Rep
Hoarding
Reimbursement
AE Reporting
EHR
Postmarket Surveillance
Population Databases
Registries
ComparativeEffectiveness
FDAs Sentinel System
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Current Device Identification

• Non-standard device identification systems
• Standards used in different ways
• Not necessarily unique or unambiguous
• Manufacturers own number/catalogue number
• Distributors apply different, proprietary
  number lot or serial number not captured
• Hospital yet different identification
  number/code
• Information on use not usually captured
• Control numbers rarely captured

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Current Device Identification
Business Name Item Number Type Item Number
BD Mfg Catalog Number 329461
BD GTIN 00382903294619
BD GTIN 30382903294610
BD GTIN 50382903294614
Cardinal Health PV Order Number BF329461
Owens Minor PV Order Number 0722329461
Owens Minor PV Order Number 0723329461
American Medical Depot Vendor Catalog Number 777127217
American Medical Depot Vendor Catalog Number 777127218
Government Sci Source Vendor Catalog Number FSC1482679CS
Government Sci Source Vendor Catalog Number FSC1482679PK
Alliance Joint Venture Vendor Catalog Number 888021932
Thomas Scientific Vendor Catalog Number 8938M25
Thomas Scientific Vendor Catalog Number 8938M28
VWR International Vendor Catalog Number BD329461
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UDI Can Improve Visibility

• Medical device recalls
• Adverse event reporting and postmarket
  surveillance
• Tracking and tracing, supply chain security and
  anti-counterfeiting/diversion (location systems)
• Comparative effectiveness (e.g., registries)
• Disaster/terror preparation and
  shortages/substitutions
• Reduce medical errors
• Documenting medical device use in patients
  EHR/PHR, hospital information systems, claims
  data
• Sentinel Initiative - strengthening FDAs ability
  to query data systems for relevant device
  information

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Medical Device Identification

• Develop a system to identify medical devices,
  which is
• Consistent
• Unambiguous (differentiates among all dimensions)
• Standardized
• Unique at all levels of packaging
• Harmonized internationally
• And facilitates the
• Storage,
• Exchange, and
• Integration of data and systems

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Future Information Lifecycle
Reimbursement
Re/order
Hospital
Expiration date?
Clinical Use
Distributor
Effectiveness
UDI Device X Lot/serial Y Exp Date Z
Recalled?
Manufacturer
EHR
Safe?
AE reporting
Recall
Registries
Surveillance
Population databases
Counterfeit

• Closed System

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FDA Amendments Act of 2007

• September 27, 2007, the FDAAA signed into law
• The Secretary shall promulgate regulations
  establishing a unique device identification
  system for medical devices requiring the label of
  devices to bear a unique identifier, unless the
  Secretary requires an alternative placement or
  provides an exception for a particular device or
  type of device. The unique identifier shall
  adequately identify the device through
  distribution and use, and may include information
  on the lot or serial number.

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HR 3962 Health Care Reform

• SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY
• (b) Electronic Exchange and Use in Certified
  Electronic Health Records of Unique Device
  Identifiers-
• (2) STANDARDS, IMPLEMENTATION CRITERIA, AND
  CERTIFICATION CRITERIA- The Secretary of Health
  and Human Services, acting through the head of
  the Office of the National Coordinator for Health
  Information Technology, shall adopt standards,
  implementation specifications, and certification
  criteria for the electronic exchange and use in
  certified electronic health records of a unique
  device identifier for each covered device
  referred to in paragraph (1), if such an
  identifier is required by section 519(f) of the
  Federal Food, Drug, and Cosmetic Act (21 U.S.C.
  360i(f)) for the device.
• (c) Unique Device Identification System- The
  Secretary of Health and Human Services, acting
  through the Commissioner of Food and Drugs, shall
  issue proposed regulations to implement section
  519(f) of the Federal Food, Drug, and Cosmetic
  Act (21 U.S.C. 360i(f)) not later than 6 months
  after the date of the enactment of this Act.

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1st Developing the Identifying Code

• Develop UDI code according to ISO 15459 GS1,
  HIBCC
• Created and maintained by the manufacturer
• Concatenating Device and Production Identifier
• Device Identifier (DI) static Manufacturer,
  make, model i.e., each catalogue number
• Production Identifier (PI) dynamic if
  currently serialized serial number if
  currently identified at the lot, the lot number,
  and expiration date
• Risk based approach DI DI lot DI serial
  (or lot and serial)

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2nd Applying code to Label

• Applied at all levels of packaging, down to the
  lowest level (the patient use level or unit of
  use)
• Human readable and/or encoded in a form of
  automatic identification technology
• Direct Part Marking (DPM) for some devices
• No specific technology would be identified
  (technology neutral)
• Identify a series of standards (linear barcode,
  2-dimensional barcode, RFID)

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3rd Developing UDI Database to Store Code and
Other Attributes (GHTF)

• Labeler Contact name, phone, email
• Device Identifier Type/Code GTIN, HIBCC
• Brand/Trade Name Description
• Device model number (or reference number)
• Size Unit of Measure/Packaging level/quantity
• Control Lot and/or Serial Number Exp. Date
• GMDN Classification code/term
• Storage condition Sterility
• Contains known, labeled allergen (e.g., latex)
• URL for additional information Web address
• For more details - see GHTF Draft Discussion
  Paper
• http//ec.europa.eu/enterprise/newsroom/cf/documen
  t.cfm?actiondisplaydoc_id5556userservice_id1

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FDAs UDI Database
The label of Medical Device 123 Size 45 Device
Identifier (Device XYZ123) Production Identifier
(Lot ABC) Expiration date (MMDDYYYY) Sterile
Latex free
Manufacturer (Acme)
Distribution
FDA

• Minimum Data Set
• For each Device Identifier
• Manufacturer and model
• GMDN Code
• Other attributes

FDA Managed
Business Rules
FDAs UDI Database
GSI GDSN
SPL
or
Other options
HIBCC UPN
or
Public User Interface
FDA eList
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4th - Adoption and Implementation

• Resolve technology issues barcodes, RFID, DPM
• Develop appropriate UDI Database
• Facilitate distributor uptake and use
• Facilitate hospital uptake and use
• Facilitate use of UDI throughout device lifecycle
• Develop medical error reduction (e.g., latex)
• Drive integration MMIS-Clinical
• Drive appropriate use of UDI in EMRs
• Determine appropriate role in reimbursement
• Address privacy concerns

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UDI Database Pilot

• Phase 1-3
• Purpose
• Assess the feasibility of collecting, storing,
  and retrieving UDI data from initial creation
  (manufacturer) to point of use (hospital) .
• Results
• Data suppliers (manufacturers) had concerns about
  data definitions, obtaining the data from various
  sources and manipulating for UDI upload.
• Participants confused about the purpose/use of
  UDID.
• Users (hospitals) liked UDID it provided data
  they regularly need - e.g. information related to
  recalls and identifying alternate
  products/manufacturers for recalls.

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UDI Database Pilot

• Phase 4
• Purpose
• Assess how UDI data will impact FDA device
  information use in current systems
• Method
• Vendors submit data via spreadsheets
• FDA analyze data for completeness and accuracy
• FDA analyze data for impact on current systems
• FDA use results to inform development of UDI
  Database
• Results
• Pending

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Limitations of UDI and UDID

• UDID contains only static information.
• Includes identifying information and other
  attributes about the device.
• UDID does NOT contain production information,
  such as lot or serial numbers.
• UDID is NOT track/trace or other similar purposes
  requiring the full UDI
• UDID provides link to Better Product Information-
  not a replacement for Recalls/Adverse Event
  Databases.

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Conclusion UDI as Foundational Element

• UDI will facilitate integration of data across
  disparate systems in the supply chain
• more efficient and effective device recalls,
• improved postmarket surveillance,
• better adverse event reporting,
• better device identification in registries,
• ability to document specific device use in
  patients Electronic Health Records,
• collection of device information in
  population-based data sets.
• BUT only if UDI is captured, stored, integrated
  and exchanged by ALL stakeholders.

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• Unique Device Identification
• www.fda.gov/MedicalDevices/DeviceRegulationandGui
  dance/UniqueDeviceIdentifiers
• Email cdrhudi_at_fda.hhs.gov